MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH & NEPHEW HYSTEROSCOPIC MORCELLATOR SYSTEM CONTROL UNIT; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 7209808

Device Problems Circuit Failure (1089); Smoking (1585); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

During a polypectomy, it was reported that, as the truclear control unit was plugged in it made a pop sound, started smoking and short circuited.No harm to the patient.It was reported that there was a backup device available and the surgeon was able to complete the procedure successfully.

Manufacturer Narrative

Visual inspection of the subject device confirmed the product failed due stalled motor.Complained issue could have been caused by a wet/shorted motor drive unit.Product replacement was sent to customer.Per results of the investigation, the root cause was determined to be an electrical component failure.At this time, no further investigation will be implemented.(b)(4).

• Brand Name: SMITH & NEPHEW HYSTEROSCOPIC MORCELLATOR SYSTEM CONTROL UNIT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4854113
• MDR Text Key: 5942020
• Report Number: 1643264-2015-00028
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7209808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1